| CTRI Number |
CTRI/2011/08/001970 [Registered on: 26/08/2011] Trial Registered Retrospectively |
| Last Modified On: |
17/08/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Allergic Conjunctivitis with Medicated Ghee |
|
Scientific Title of Study
|
Clinical evaluation of Mahatriphaladya Ghrita in the management of Allergic Conjunctivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCRAS ACT-AC-2010 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sadhana Parajuli |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
MD Scholar – Department of Shalakya Tantra
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8000714065 |
| Fax |
|
| Email |
sadhanaparajuli@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Rajagopal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Shalakya Tantra
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Rajagopal |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Shalakya Tantra
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gujarat Ayurved University |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sadhana Parajuli |
Department of Shalakya Tantra |
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT |
8000714065
sadhanaparajuli@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Allergic Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mahatriphaladya ghrita |
15mlBD in empty stomach with luke warm water for 3 months
Ingredients:
Bringaraja - Eclipta alba
Vasa - Adhatoda vasica
Satavari -Aspargus racemosus
Gudhici- Tinosporia cordifolia
Amalaki -Emblica officinalis
Pippali - Pipper longum
Draksa - Vitis vinifera
Haritaki- Terminalia chebula
Vibhitaki-Terminalia bellerica
Yastimadhu- Glycyrrhiza glabra
Kantakari-Solanum saurattense
Neelotpala-Nymphae stellate
Ajaksheera -Capra hircus
Sita - Sugar
Goghrita -Butyrum deparatum
|
| Comparator Agent |
Not applicable |
Since there is only one group in the study |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of Abhishyanda (Allergic Conjunctivitis) |
|
| ExclusionCriteria |
| Details |
Patients having complications like corneal involvement like marginal corneal ulcer, dacryocyctitis, trachoma, kerato conjunctivitis etc.
Patients below 16 years and above 36 years
Infective conjunctivitis
Patients having genetic predisposition to allergy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measure is
itching,
ropy discharge,
watering,
burning,
redness,
Foreign body sensation |
14, 28, 42, 56, 70, 84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood investigations - Serum IgE (Immunoglobulin - E) and Absolute Eosinophil Count |
84 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a open single trial, study to evaluate the efficacy of Mahatriphaladya Ghrita in the management Allergic conjunctivitis. The primary outcome measure is itching, ropy discharge, watering, burning, redness, Foreign body sensation on 14, 28, 42,56,70,84 days and the secondary outcome measures are IgE and Absolute eosinophil count on 84th day |